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Patent 2303204 Summary

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(12) Patent Application: (11) CA 2303204
(54) English Title: TISSUE COLLECTOR
(54) French Title: COLLECTEUR DE TISSUS
Status: Deemed Abandoned and Beyond the Period of Reinstatement - Pending Response to Notice of Disregarded Communication
Bibliographic Data
(51) International Patent Classification (IPC):
  • A61B 10/00 (2006.01)
  • A61B 17/32 (2006.01)
  • A61M 1/00 (2006.01)
(72) Inventors :
  • GABER, BENNY (Israel)
(73) Owners :
  • BENNY GABER
(71) Applicants :
  • BENNY GABER (Israel)
(74) Agent: GOWLING WLG (CANADA) LLP
(74) Associate agent:
(45) Issued:
(86) PCT Filing Date: 1998-08-17
(87) Open to Public Inspection: 1999-03-18
Availability of licence: N/A
Dedicated to the Public: N/A
(25) Language of filing: English

Patent Cooperation Treaty (PCT): Yes
(86) PCT Filing Number: PCT/IL1998/000386
(87) International Publication Number: WO 1999012476
(85) National Entry: 2000-03-09

(30) Application Priority Data:
Application No. Country/Territory Date
121734 (Israel) 1997-09-10
124359 (Israel) 1998-05-07

Abstracts

English Abstract


A tissue collector (70) comprising a cannula (12) adapted for insertion into a
uterus, the cannula (12) including a flexible distal portion (18), and at
least one guide wire (74) attached to the distal portion (18) of the cannula
(12), wherein movement of the at least one guide wire (74) flexes the distal
portion (18) of the cannula (12). There is also provided a suction device
(100) comprising a syringe (102) including a distal barrel (104) which extends
from a proximal barrel (106), the proximal barrel (106) having a larger
diameter than the distal barrel (104), a plunger element (112) disposed inside
the proximal barrel (106), the plunger element (112) being adapted to
sealingly slide inside the proximal barrel (106), and a plunger (108) that
passes through the plunger element (112), wherein when the plunger (108) is
pulled proximally and starts to enter the proximal barrel (106), the plunger
(108) is received in a recess (113) formed in the plunger element (112), such
that when the plunger (108) is pulled further proximally, the plunger (108)
moves together with the plunger element (112) and the plunger element (112)
serves as a new distal end of the plunger (108) during sliding travel in the
proximal barrel (106).


French Abstract

Cette invention concerne un collecteur (70) de tissus comportant une canule (12) conçue pour être introduite dans un utérus. Cette canule (12) présente une partie distale souple (18) et au moins un fil-guide (74) fixé à cette partie distale (18). Le déplacement d'au moins un fil-guide (74) courbe ladite partie distale (18). Cette invention se rapporte également à un dispositif d'aspiration (100) comportant une seringue (102) dotée d'une enveloppe tubulaire distale (104) qui s'étend à partir d'une enveloppe tubulaire proximale (106) dont le diamètre est plus grand que celui de l'enveloppe distale (104); d'un poussoir (112) installé à l'intérieur de cette enveloppe proximale (106) et conçu pour coulisser de manière étanche dans cette dernière; et d'un piston (108) qui passe dans ledit poussoir (112). Lorsque le piston est poussé dans le sens proximal et commence à pénétrer dans l'enveloppe proximale (106), le piston (108) est réceptionné dans un évidement (113) formé dans le poussoir (112) de sorte que lorsque l'on pousse encore le piston (108) dans le sens proximal, le piston (108) se déplace avec le poussoir (112), ce dernier servant de nouvelle extrémité distale du piston (108) au cours de son déplacement coulissant dans l'enveloppe proximale (106).

Claims

Note: Claims are shown in the official language in which they were submitted.


CLAIMS
What is claimed is:
1. A tissue collector (70) comprising:
a deformable scraper (16) which is capable of being deformed from an
undeformed
configuration to a deformed configuration and which scrapes a tissue while
moving between said
undeformed configuration and said deformed configuration;
a deformer (22) which deforms said deformable scraper (16); and
a suction device (20, 100) which sucks material scraped by said deformable
scraper (16);
characterized by
said scraper (16) being disposed in a cannula (12) comprising a flexible
distal
portion (18), and wherein at least one guide wire (74) is attached to the
distal portion (18) of the
cannula (12), wherein movement of said at least one guide wire (74) flexes the
distal portion (18)
of said cannula (12).
2. The tissue collector (70) according to claim 1 wherein said at least one
guide wire
(74) is disposed through a lumen (72) formed through said cannula (12).
3. The tissue collector (70) according to claim 2 wherein said lumen (72)
constrains
movement of said at least one guide wire (74) in a direction generally along a
longitudinal axis
(32) of said cannula (12).
4. The tissue collector (70) according to claim 1 wherein a proximal portion
of said
at least one guide wire (74) is pivotally attached about a fulcrum (83) to a
lever (82) such that
movement of said lever (82) flexes the distal portion (18) of said cannula
(12).
5. The tissue collector (70) according to claim 1 and comprising a pair of
said guide
wires (74, 76), wherein generally proximal movement of one of said guide wires
(74) causes
flexing of said distal portion (18) of said cannula (12) in a direction
different to that caused by
generally proximal movement of the other guide wire (76).
6. The tissue collector (70) according to claim 5 and wherein each said guide
wire
(74, 76) is disposed in a separate lumen formed in said cannula (12).
7. The tissue collector (70) according to claim 1 and wherein said at least
one guide
wire (74) is sufficiently stiff so as to be able to push distally as well as
pull proximally the distal
portion (18) of said cannula (12).
8. The tissue collector (70) according to claim 1 and wherein said at least
one guide
wire (74) is attached to said cannula (12) at a fulcrum point (91), thereby
causing said cannula
12

(12) to bend at a buckling pocket (89) when said at least one guide wire (74)
pushes distally the
distal portion (18) of said cannula (12).
9. The tissue collector (10, 70) according to claim 1 and comprising:
a syringe (102) comprising a distal barrel (104) which extends from a proximal
barrel (106), said proximal barrel (106) having a larger diameter than said
distal barrel (104);
a plunger element (112) disposed inside said proximal barrel (106), said
plunger
element (112) being adapted to sealingly slide inside said proximal barrel
(106); and
a plunger (108) that passes through said plunger element (112), wherein when
said
plunger (108) is pulled proximally and starts to enter said proximal barrel
(106), said plunger
(108) is received in a recess (113) formed in said plunger element (112), such
that when said
plunger (108) is pulled further proximally, said plunger (108) moves together
with said plunger
element (112) and said plunger element (112) serves as a new distal end of
said plunger (108)
during sliding travel in said proximal barrel (106).
10. A tissue collector (10, 70) comprising:
a deformable scraper (16) which is capable of being deformed from an
undeformed
configuration to a deformed configuration and which scrapes a tissue while
moving between said
undeformed configuration and said deformed configuration;
a deformer (22) which deforms said deformable scraper (16); and
a suction device (100) which sucks material scraped by said deformable scraper
(16);
characterized by
said suction device (100) comprising a syringe (102) comprising a distal
barrel
(104) which extends from a proximal barrel (106), said proximal barrel (106)
having a larger
diameter than said distal barrel (104);
a plunger element (112) disposed inside said proximal barrel (106), said
plunger
element (112) being adapted to sealingly slide inside said proximal barrel
(106); and
a plunger (108) that passes through said plunger element (112), wherein when
said
plunger (108) is pulled proximally and starts to enter said proximal barrel
(106), said plunger
(108) is received in a recess (113) formed in said plunger element (112), such
that when said
plunger (108) is pulled further proximally, said plunger (108) moves together
with said plunger
element (112) and said plunger element (112) serves as a new distal end of
said plunger (108)
during sliding travel in said proximal barrel (106).
13

11. The tissue collector (70) according to claim 1 and characterized by said
scraper
(16) being stiffer when moved towards a proximal end of said collector (10)
than when moved
towards a distal end of said collector (10).
12. The tissue collector (10, 70) according to claim 10 and characterized by
said
scraper (16) being stiffer when moved towards a proximal end of said collector
(10) than when
moved towards a distal end of said collector (10).
13. A tissue collector (10) comprising:
a deformable scraper (16) which is capable of being deformed from an
undeformed
configuration to a deformed configuration and which scrapes a uterus while
moving between said
undeformed configuration and said deformed configuration;
a deformer (22) which deforms said deformable scraper (16); and
a suction device (20, 100) which sucks material scraped by said deformable
scraper (16);
characterized by
said scraper (16) being stiffer when moved towards a proximal end of said
collector (10) than when moved towards a distal end of said collector (10).
14. The tissue collector (10) according to claim 13 wherein said scraper (16)
substantially scrapes said uterus only when moved towards said proximal end of
said collector
(10).
15. The tissue collector (10) according to claim 13 and wherein said scraper
(16)
comprises a flexible tongue (26) adjacent and proximal to a generally rigid
tongue (28), wherein
said flexible tongue (26) when moved towards said proximal end of said
collector (10) flexes
towards and abuts against said rigid tongue (28) and when moved towards said
distal end of said
collector (10) flexes away from and does not abut against said rigid tongue
(28).
16. The tissue collector (10) according to claim 15 and wherein said flexible
tongue
(26) protrudes further from a longitudinal axis (32) of said collector (10)
than said rigid tongue
(28).
17. The tissue collector (10) according to claim 13 and also comprising a
cannula (12)
having a first lumen (40) and a second lumen (42), wherein said deformable
scraper (16) is
14

disposed in said first lumen (40) and at least a portion of said scraper (16)
is protrudable through
an aperture (14) formed in said first lumen (40), and wherein said deformer
(22) comprises a wire
(24) coupled to said deformable scraper (16), said wire (24) passing through
said second lumen
(42).
18. The tissue collector (10) according to claim 17 and wherein said second
lumen
(42) has a passageway (44) formed therein for flow therethrough of a fluid
towards a distal
portion (18) of said cannula (12).
19. The tissue collector (10) according to claim 18 and comprising a bleed
valve (48)
for controlling said flow of said fluid through said passageway (44).
20. The tissue collector (10) according to claim 13 and also comprising:
a cannula (12) having an inner surface; and
a wiping device (50, 60) that wipes particles from said inner surface of said
cannula (12).
21. The tissue collector (10) according to claim 20 and wherein said suction
device
(20) imparts a fluid force on said wiping device (50, 60) to propel said
wiping device (50, 60)
through said cannula (12).
22. The tissue collector (10) according to claim 20 and wherein said wiping
device
(50, 60) comprises an elastic ball (52, 62) which is disposed in said cannula
(12) and touches said
inner surface.
23. The tissue collector (10) according to claim 22 wherein said elastic ball
(62) is
initially attached to said suction device (20) and is detachable from said
suction device (20) upon
said suction device (20) imparting a fluid force on said elastic ball (62).
15

Description

Note: Descriptions are shown in the official language in which they were submitted.


CA 02303204 2000-03-09
WO 99/12476 PCT/IL98/00386
TISSUE COLLECTOR
FIELD OF THE IIWENTION
The present invention relates to gynecological instruments generally, and
particularly to a uterine tissue collector which scrapes a uterus and collects
scraped uterine
material by suction.
BACKGROUND OF THE INVENTION
Obtaining samples of cervical and uterine tissue is normally performed in the
art by
one of three methods: dilation of the cervix and curettage of the endometrium,
known as D & C;
suction without dilation of the cervix via a small diameter tube, known as
aspiration; or by suction
curettage. D & C and suction curettage are capable of collecting as much
cervical or uterine
material as required, but require anesthesia. Aspiration with a small diameter
tube does not
normally require anesthesia but is not capable of obtaining amounts of tissue
comparable to those
obtainable with D & C. In order to obtain amounts of tissue comparable to
those obtainable with
D & C, aspiration must be performed with a large tube which requires
anesthesia.
An endometrial suction curette, called the Pipelle de Cornier, manufactured by
PRODIMED of France, may be used to scrape endometrial material with the distal
end of a
sheath of the curette. However, the scraping area is limited by the relatively
small diameter of the
sheath.
There are several instruments in the patent literature for scraping a uterus
and/or
collecting scraped material. U.S. Patent 5,224,488 to Neuffer describes a
biopsy needle insertable
into a body with a deformable strip which can cut tissue and which protrudes
laterally outwards of
the needle. The strip does not move back and forth but rather cuts when the
user rotates the
needle about its axis. The strip is manually pushed laterally outwards of the
needle by turning a
screw.
U.S. Patent 4,895,166 to Farr describes a rotatable cutter for penetrating
into and
cutting tissue in a lumen (body cavity). The cutting tool includes two spaced
external segments of
a conical generally hollow portion with cutting surfaces at their edges. A
vacuum is applied to
remove fragments of cut tissue. Again the cutter cuts by rotating, not by
moving back and forth.
U.S. Patent 5,217,479 to Shuler describes a rotary surgical cutting instrument
which cuts with an inner member rotating inside an outer member. The inner
member is provided
with two symmetric rows of triangular cutting teeth and the outer member has a
distal cutting
aperture. Here, too, the instrument cuts by rotating, not by moving back and
forth.
U.S. Patent 4,340,066 to Shah describes an endometrial sampling device
including
a cannula which has a transverse slot with scraping edges and a sharp point,
and which is

CA 02303204 2000-03-09
WO 99/12476 PCT/IL98/00386
insertable into the cervix. By manually moving the cannula and scraping with
the scraping edges,
one can collect endometrial tissue. The cutter cuts by manually moving the
cannuia and scraping
material, and not by moving back and forth.
U.S. Patent 5,335,671 to Clement describes a surgical assembly for removal of
body tissue including a movable cutter inside a cannula which is insertable
into a desired location
in a patient. The cutter is rigid and cuts by shearing against an aperture in
the cannula. A vacuum
may be provided for removing cut material. The cutter cuts by shearing in one
direction, not by
moving back and forth.
Applicant/assignee discloses in PCT Patent Application PCT/LTS96/02702 and
U.S. Patent Application 08/607,901, the disclosure of which is incorporated
herein by reference, a
uterine tissue collector including a deformable scraper which is capable of
being deformed from
an undeformed configuration to a deformed configuration. The scraper scrapes a
uterus while
moving between the undeformed configuration and the deformed configuration.
This ~ uterine
tissue collector has already enjoyed much success in clinical trials.
SUMMARY OF THE INVENTION
The present invention seeks to provide several improvements relating to the
uterine tissue collector disclosed in U.S. Patent Application 08/607,901. One
of the improvements
is a flexible scraper which substantially scrapes the uterus only when moved
towards a proximal
end (the collection end) of a cannula of the uterine tissue collector. This
novel structure ensures
that the scraper scrapes and "rakes" the uterine material into the cannula and
not away from the
cannula.
Another improvement is constructing the cannula as a double lumen. One lumen
is
used for the deformable scraper and a smaller lumen is used for a wire which
is attached to and
imparts movement to the scraper. This construction better isolates the wire
from the uterine
material. In addition, the wire lumen has a passageway for permitting a fluid,
such as ambient air,
to flow towards a distal end of the larger, scraper lumen. This flow of
"bleed" air helps create a
positive pressure on the distal side of any lump of matter in the vicinity of
the scraper. The
positive pressure allows a suction device proximal to the lump of matter to
efficiently suck and
collect the lump of matter.
Yet another lumen may be provided as a passageway for a guide wire which can
be
used to "steer" the cannula. The cannula is flexible or is constructed with
notches or a thin-walled
section, so that the cannula tip is bendable. The distal end of the guide wire
is attached to the
cannula near the tip, and the proximal end of the guide wire is attached to a
finger or hand
2

CA 02303204 2000-03-09
WO 99/12476 PCT/IL98/00386
controlled lever. By pulling on the lever to the right or left, the tip of the
cannula is accordingly
bent or flexed, thereby significantly increasing the area which may be scraped
and/or raked.
Still another improvement is an elastic ball which wipes an inner surface of
the
scraper lumen, the wiped material being sucked and collected by the suction
device, thereby
increasing the collection efficiency of the uterine tissue collector.
Another improvement is constructing the suction device as a two-stage syringe.
The syringe has a double barrel, a distal barrel which extends from a proximal
barrel, the proximal
barrel having a larger diameter than the distal barrel. A plunger sealingly
slides in the distal barrel
like any conventional plunger. When the plunger is completely pulled
proximally through the
distal barrel and enters the proximal barrel, the distal tip of the plunger is
pulled into engagement
with a plunger element so that the plunger element is fixed to the distal tip
of the plunger. The
plunger element now acts as a new tip of the plunger in its travel in the
proximal barrel. Since the
proximal barrel has a larger area than the distal barrel, the amount of
material which can be
collected with the syringe is significantly greater than a conventional
syringe of the prior art which
has only one barrel of the size of the distal barrel of the present invention,
and yet the smaller
diameter of the distal barrel allows entry of the syringe of the present
invention into smaller
openings than possible with syringes of the prior art which have a single
barrel of the size of the
proximal barrel.
It is noted that throughout the specification and claims, the term "uterine
tissue"
refers to any material in the cervical canal and uterine cavity, e.g. uterine
layering, cervical
mucosa, gestational products, endometrium or tumoral substances. In the
specification and claims,
the term "uterus" encompasses the cervical canal and uterine cavity. It is
also appreciated that the
present invention, although described herein for scraping a uterus, is readily
applicable for
scraping any tissue.
There is thus provided in accordance with a preferred embodiment of the
present
invention a tissue collector including a deformable scraper which is capable
of being deformed
from an undeformed configuration to a deformed configuration and which scrapes
a tissue while
moving between the undeformed configuration and the deformed configuration, a
deformer which
deforms the deformable scraper, and a suction device which sucks material
scraped by the de-
formable scraper, characterized by the scraper being stiffer when moved
towards a proximal end
of the collector than when moved towards a distal end of the collector.
In accordance with a preferred embodiment of the present invention the scraper
substantially scrapes the uterus only when moved towards the proximal end of
the collector.
3

CA 02303204 2000-03-09
WO 99/12476 PCT/IL98/00386
Further in accordance with a preferred embodiment of the present invention the
scraper includes a flexible tongue adjacent and proximal to a generally rigid
tongue, wherein the
flexible tongue when moved towards the proximal end of the collector flexes
towards and abuts
against the rigid tongue and when moved towards the distal end of the
collector flexes away from
and does not abut against the rigid tongue.
Still further in accordance with a preferred embodiment of the present
invention
the flexible tongue protrudes further from a longitudinal axis of the
collector than the rigid
tongue.
Additionally in accordance with a preferred embodiment of the present
invention
the uterine tissue collector includes a cannula having a first lumen and a
second lumen, wherein
the deformable scraper is disposed in the first lumen and at least a portion
of the scraper is
protrudable through an aperture formed in the first lumen, and wherein the
deformer includes a
wire coupled to the deformable scraper, the wire passing through the second
lumen.
In accordance with a preferred embodiment of the present invention the second
lumen has a passageway formed therein for flow therethrough of a fluid towards
a distal end of
the first lumen. Preferably there is also provided a bleed valve for
controlling the flow of the fluid
through the passageway.
In accordance with a preferred embodiment of the present invention the uterine
tissue collector includes a cannula having an inner surface, and a wiping
device that wipes
particles from the inner surface of the cannula. Preferably the suction device
imparts a fluid force
on the wiping device to propel the wiping device through the cannula.
Further in accordance with a preferred embodiment of the present invention the
wiping device includes an elastic ball which is disposed in the cannula and
touches the inner
surface.
Still further in accordance with a preferred embodiment of the present
invention
the elastic ball is initially attached to the suction device and is detachable
from the suction device
upon the suction device imparting a fluid force on the elastic ball.
There is also provided in accordance with a preferred embodiment of the
present
invention a uterine tissue collector including a cannula adapted for insertion
into a uterus, the
cannula including a flexible distal portion, and at least one guide wire
attached to the distal
portion of the cannula, wherein movement of the at least one guide wire flexes
the distal portion
of the cannula. Preferably the at least one guide wire is disposed through a
lumen formed through
the cannula. Preferably the lumen constrains movement of the at least one
guide wire in a
direction generally along a longitudinal axis of the cannula.
4

CA 02303204 2000-03-09
WO 99/12476 PCT/IL98/00386
In accordance with a preferred embodiment of the present invention a proximal
portion of the at least one guide wire is pivotally attached about a fulcrum
to a lever such that
movement of the lever flexes the distal portion of the cannula.
Further in accordance with a preferred embodiment of the present invention the
uterine tissue collector includes a pair of guide wires, each guide wire being
disposed in a separate
lumen formed in the cannula, wherein generally proximal movement of one of the
guide wires
causes flexing of the distal portion of the cannula in a direction generally
opposite to that caused
by generally proximal movement of the other guide wire.
Still further in accordance with a preferred embodiment of the present
invention
the at least one guide wire is su~ciently stiff so as to be able to push as
well as pull the distal
portion of the cannula.
There is also provided in accordance with a preferred embodiment of the
present
invention a suction device including a syringe including a distal barrel which
extends from a
proximal barrel, the proximal barrel having a larger diameter than the distal
barrel, a plunger
element disposed inside the proximal barrel, the plunger element being adapted
to sealingly slide
inside the proximal barrel, and a plunger that passes through the plunger
element, wherein when
the plunger is pulled proximally and starts to enter the proximal barrel, a
proximal face of a distal
end of the plunger is received in a recess formed in the plunger element, such
that when the
plunger is pulled further proximally, the plunger moves together with the
plunger element and the
plunger element serves as a new distal end of the plunger during sliding
travel in the proximal
barrel.
BRIEF DESCRIPTION OF THE DRAWINGS
The present invention will be understood and appreciated more fully from the
following detailed description, taken in conjunction with the drawings in
which:
Fig. 1 is a simplified, partially sectional illustration of a uterine tissue
collector
constructed and operative in accordance with a preferred embodiment of the
present invention;
Fig. 2 is a simplified, partially sectional illustration of a scraper used in
the uterine
tissue collector of Fig. I;
Figs. 3A and 3B are simplified side view illustrations of the operation of the
scraper of Fig. 2 in accordance with a preferred embodiment of the present
invention, wherein
Fig. 3A shows the scraper being moved proximally and scraping a uterine wall
and wherein Fig.
3B shows the scraper being moved distally and not scraping the uterine wall;
Fig. 4 is a simplified partially sectional illustration of the structure of a
lumen
through which passes a wire attached to the scraper of Fig. 2 and through
which flows fluid to a
s

CA 02303204 2000-03-09
WO 99/12476 PCT/IL98/00386
distal end of the uterine tissue collector in accordance with a preferred
embodiment of the present
invention;
Fig. 5 is a simplified, partially sectional illustration of a wiping device
constructed
and operative in accordance with a preferred embodiment of the present
invention and useful in
wiping an inner surface of the uterine tissue collector of Figs. I-4;
Figs. 6A and 6B are simplified illustrations of the operation of the wiping
device of
Fig. 5, wherein Fig. 6A illustrates an elastic ball pushed distally into a
channel and Fig. 6B
illustrates the elastic ball being forced distally in a cannula and wiping an
inner perimeter of the
cannula;
Figs. 7A and 7B are simplified, partially sectional illustrations of a wiping
device
constructed and operative in accordance with another preferred embodiment of
the present
invention, wherein Fig. 7A illustrates an elastic ball initially attached to a
syringe and Fig. 7B
illustrates the elastic ball being detached from the syringe and forced
distally in a cannula and
wiping an inner perimeter of the cannula;
Fig. 8 is a simplified pictorial illustration of a uterine tissue collector
constructed
and operative in accordance with yet another preferred embodiment of the
present invention, the
uterine tissue collector including a guide wire which flexes a bendable
cannula;
Figs. 9A and 9B are simplified enlarged illustrations of two dit~erent
configurations
of a bendable portion of the cannula of Fig. 8;
Figs. 10A, lOB and IOC are simplified, enlarged sectional illustration of the
cannula of Fig. 8, showing three different configurations for passage of guide
wires;
Fig. 11 is a simplified pictorial illustration of the uterine tissue collector
of Fig. 8
being flexed by a user;
Fig. 12A is a simplified pictorial illustration of a suction device, usefirl
with any of
the uterine tissue collectors of the present invention, constructed and
operative in accordance with
a preferred embodiment of the present invention;
Fig. 12B is an enlarged illustration of a distal portion of the suction device
of Fig.
I2A; and
Figs. 13A, 13B and 13C are enlarged simplified pictorial illustrations of the
suction
with a plunger fully pushed into a distal barrel of a syringe, with the
plunger proximally retracted
from the distal barrel and moved into a proximal barrel of the syringe, and
with the plunger
retracted into the proximal barrel, respectively.
DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT
G

CA 02303204 2000-03-09
WO 99/12476 PCT/IL98/00386
Reference is now made to Fig. 1 which illustrates a uterine tissue collector
10
constructed and operative in accordance with a preferred embodiment of the
present invention.
Uterine tissue collector 10 includes a hollow cannula 12 shaped for insertion
into a
uterus. Cannula 12 may be straight or bent, Cannula 12 has an aperture 14 and
a deformable
scraper 16 disposed at a distal portion 18 of cannula 12. The operation of
scraper 16 will be
described in detail further below with reference to Figs. 2, 3A and 3B.
Uterine tissue collector 10 also comprises a suction device such as a syringe
20
and a deformer, such as an electromagnetic vibrator 22 coupled to scraper 16
by means of a wire
24. The construction and operation of the suction device and deformer are in
accordance with the
teachings of U.S. Patent Application 08/607,901. In a preferred embodiment of
the present
invention, syringe 20 and cannula 12 form a disposable assembly. After
collection of uterine
material and examination thereof, the assembly may be discarded.
Reference is now made to Fig. 2 which illustrates more clearly scraper 16.
Scraper
16 preferably includes a flexible tongue 26 adjacent and proximal to a
generally rigid tongue 28.
Tongues 26 and 28 may be attached to each other and may be formed from a
single piece of
material, such as plastic. An end 30 of wire 24 is preferably fixedly attached
to rigid tongue 28.
Flexible tongue 2b is preferably longer than rigid tongue 28, i.e., flexible
tongue 26 protrudes
further from a longitudinal axis 32 of uterine tissue collector 10 than rigid
tongue 28.
Reference is now made to Figs. 3A and 3B which illustrate the operation of
scraper 16. In Fig. 3A, it is seen that flexible tongue 26 is placed against a
uterine wall 34 and is
poised for scraping. As flexible tongue 26 is moved by wire 24 proximally in
the direction of an
arrow 36, flexible tongue 26 flexes towards and abuts against rigid tongue 28.
Rigid tongue 28
thus arrests the flexure of flexible tongue 26 and flexible tongue 26 is
maintained stiff during its
proximal scraping motion against uterine wall 34. In contrast, as shown in
Fig. 3B, when flexible
tongue 26 is moved by wire 24 towards distal portion 18, flexible tongue 26
flexes away from and
does not abut against rigid tongue 28. Because of its flexibility, flexible
tongue 26 simply glides
over uterine wall 34 during the distal travel and does not substantially
scrape wall 34. Thus,
scraper 16 is stii~er when moved proximally than when moved distally.
Referring again to Fig. 2, it is seen that cannula 12 is formed with a first
lumen 40
and a second lumen 42. Scraper 16 is disposed in first lumen 40 and wire 24
passes through
second lumen 42.
Reference is now made to Fig. 4 which further illustrates the structure of
second
lumen 42. Preferably second lumen 42 has a passageway 44 formed therein for
flow therethrough
of a fluid, such as ambient air, towards a distal portion 18 of cannula 12 and
of first lumen 40.

CA 02303204 2000-03-09
WO 99/12476 PCT/IL98/00386
When cannula 12 is pressed against uterine wall 34 (Fig. 3A), there is
substantially zero or
negative pressure inside cannula 12 during suction applied by syringe 20 (Fig.
1 ). As seen in Fig.
4, if a lump 46 of matter is lodged inside cannula 12 in the vicinity of
scraper 16, and a vacuum or
near-vacuum exists on the distal side of lump 46, syringe 20 may have
difficulty in pulling lump 46
through cannula 12. The flow of fluid, such as "bleed" air, through passageway
44 helps create a
positive pressure on the distal side of lump 46 to help syringe 20 ei~cientiy
suck and collect lump
46. A bleed valve 48 may be provided for controlling flow of the bleed fluid
through passageway
44.
Reference is now made to Fig. 5 which illustrates a wiping device 50
constructed
and operative in accordance with a preferred embodiment of the present
invention. Wiping device
50 preferably includes an elastic ball 52 snugly fitted into a channel 54.
Elastic ball 52 may be
made of any elastomer, such as rubber or neoprene. Channel 54 is in fluid
communication with
both first lumen 40 and syringe 20, such that any matter collected is sucked
through first lumen 40
via channel 54 to syringe 20.
Initially elastic ball 52 is lodged in channel 54 above, or more precisely,
out of the
way of an inlet 56 between channel 54 and syringe 20. Thus, in this position
matter is free to flow
to syringe 20. Elastic ball 52 in this position abuts against a piston 58
which is slidable in channel
54.
The operation of wiping device 50 will now be described. After having used the
uterine tissue collector to scrape and collect a desired amount of uterine
material, the disposable
assembly of syringe 20 and cannula 12 is removed from the hand-held piece
shown in Fig. I that
comprises vibrator 22. Syringe 20 typically contains a large amount of
collected uterine material,
and the syringe plunger is pulled almost, but not completely proximally in
syringe 20.. The distal
end of cannula 12 is then dipped in a setting solution, such as formalin, and
the syringe plunger is
then pulled completely proximally to suck fonmalin through cannula 12 and into
syringe 20,
whereupon the formalin mixes with the collected material. The mixture of
formalin and material is
then discharged into a collection vessel, such as a vial. Syringe 20 is then
used to draw therein a
second amount of formalin. Up to this point, elastic ball 52 has remained out
of the path of the
formalin and material. Syringe 20 is then used to draw in formalin a second
time and about 80-
90% of the formalin-material mixture is discharged into the collection vessel.
Reference is now made to Figs. 6A and 6B which illustrate how elastic ball 52
is
employed. Fig. 6A illustrates syringe 20 after having drawn in formalin for
the second time and
discharged about 80-90% of the mixture. Piston 58 is then pushed in the
direction of an arrow 61,
thereby pushing elastic ball 52 distally along channel 54 and distally below
inlet 56. As seen in Fig.
R

CA 02303204 2000-03-09
WO 99/12476 PCT/IL98/00386
6B, the plunger of syringe 20 is then pushed distally, thereby applying a
fluid force on elastic ball
52 and propelling elastic ball 52 distally through the length of lumen 40 to
distal portion 18 of
cannula 12. As elastic ball 52 moves through lumen 40, it wipes an inner
perimeter of lumen 40
and discharges the formalin and other contents of lumen 40 out of distal
portion 18 into a
collection vial (not shown). Thus elastic ball 52 increases the collection
efficiency of the uterine
tissue collector.
Reference is now made to Figs. 7A and 7B which illustrate a wiping device 60
constructed and operative in accordance with another preferred embodiment of
the present
invention. In this embodiment, wiping device 60 includes an elastic ball 62
initially attached to a
pin 64 fixedly attached to a plunger 66 of syringe 20. As described
hereinabove, aRer having used
the uterine tissue collector to scrape and collect a desired amount of uterine
material, the
disposable assembly of syringe 20 and cannula 12 is removed from the hand-held
piece shown in
Fig. 1 that comprises vibrator 22. Syringe 20 typically contains a large
amount of collected uterine
material, and plunger 66 is pulled almost, but not completely proximally in
syringe 20. The distal
end of cannula 12 is then dipped in a setting solution, such as formalin, and
plunger 66 is drawn
proximally to suck formalin through cannula 12 and into syringe 20, whereupon
the formalin
mixes with the collected material. The position of plunger 66 after having
sucked in formalin is
shown in Fig. 7A. At this point plunger 66 is not completely pulled proximally
in syringe 20 and
the sucking of fonmalin adds about 20% to the volume of matter in syringe 20.
In Fig. 7B, plunger 66 of syringe 20 is pushed distally and elastic ball 62
enters
inlet 56. Further distal pushing of plunger 66 applies a fluid force on
elastic ball 62 thereby
dislodging ball 62 from pin 64. Once ball 62 has been dislodged from pin 64,
the fluid force
propels elastic ball 62 through channel 54 and lumen 40 to distal portion 18
(not shown in Fig.
7B) of cannula 12. As described hereinabove, as elastic ball 62 moves through
lumen 40, it wipes
an inner perimeter of lumen 40 and discharges the formalin and other contents
of lumen 40 out of
distal portion 18 into a collection vial (not shown). Thus, preferably the
embodiment of Figs. 7A
and 7B uses a wiping device which wipes the inner surface of cannula 12 after
one ingress of
formaIin, whereas the embodiment of Figs. 6A and 6B uses a wiping device which
wipes the inner
surface of cannula 12 after two ingresses of formalin.
Reference is now made to Figs. 8-1 I which illustrate a uterine tissue
collector 70
constructed and operative in accordance with yet another preferred embodiment
of the present
invention. Uterine tissue collector 70, like uterine tissue collector 10,
includes cannula 12 which is
formed with first lumen 40 and second lumen 42 (both seen in Fig. 10). As
described hereinabove,
0

CA 02303204 2000-03-09
WO 99/12476 PCTlIL98/00386
scraper 16 (not shown in Figs. 8-11) is disposed in first lumen 40 and wire 24
passes through
second lumen 42.
Uterine tissue collector 70 differs from uterine tissue collector 10 in that
collector
70 includes a third lumen 72 which serves as a passageway for a guide wire 74
which can be used
to flex cannula 12. As seen in Fig. 8, the distal end of guide wire 74 is
attached to distal portion
18 of cannula 12. Guide wire 74 preferably has sufficient stiffness to push as
well as pull distal
portion I8. Cannula 12 is preferably constructed of a flexible material.
Additionally or
alternatively, a portion of cannula 12 may be constructed with a relatively
low bending moment to
permit easy flexing of distal portion 18 of cannula 12. For example, as seen
in Fig. 9A, cannula 12
may have a thin-walled section 78, or as seen in Fig. 9B, cannula 12 may be
formed with notches
80 so as to make the cannula tip bendable sideways. Thin-walled section 78 and
notches 80 may
be formed around a portion of the perimeter of cannula 12 or all around the
perimeter.
Refernng to Fig. 8, it is seen that the proximal end of guide wire 74 is
attached to
a lever 82 which is preferably pivotally attached about a fulcrum 83 to a
handle 84. Guide wire 74
is preferably bent about an attachment point 86 in lever 82. As seen in Fig.
11, by pushing guide
wire 74 with lever 82 in the direction of an arrow 90, distal portion 18 of
cannula 12 is
accordingly bent or flexed generally in the direction of an arrow 92. The
flexing action
significantly increases the area which may be scraped and/or raked with
uterine tissue collector
70. Guide wire 74 is preferably coupled to a motor 93 for automatic flexing.
Motor 93 is
preferably the same motor used to vibrate deformable scraper 16.
Alternatively, lever 82 may be
bent with the index finger.
It is seen in Fig. I1 that guide wire 74 is preferably attached to cannula 12
at a
fulcrum point 91. This arrangement causes lever 82 to bend cannula 12 at a
buckling pocket 89,
thereby significantly increasing the amount that cannula 12 bends.
Alternatively, a second guide wire 76 may be used in conjunction with guide
wire
74, guide wire 76 being attached to a side of distal portion 18 opposite to
guide wire 74. Each
guide wire 74 and 76 may be disposed in a separate lumen formed in cannula 12
(Fig. 1OA), or
may alternatively be disposed either inside lumen 40 (Fig. lOB) or outside of
cannula 12 (Fig.
lOC). In such an embodiment, generally proximal movement of one of the guide
wires causes
flexing of distal portion 18 in a direction generally opposite to that caused
by generally proximal
movement of the other guide wire.
Reference is now made to Figs. 12A-13C which illustrate a suction device 100,
useful with a uterine tissue collector such as any of the uterine tissue
collectors of the present

CA 02303204 2000-03-09
WO 99/12476 PCT/IL98/00386
invention, constructed and operative in accordance with a preferred embodiment
of the present
invention. The details of the construction of suction device 100 are best seen
in Figs. 13A-13C.
Suction device 100 comprises a two-stage syringe 102. Syringe 102 preferably
includes a distal barrel 104 which extends from and is in fluid communication
with a proximal
barrel 106, proximal barrel 106 having a larger diameter than distal barrel
104. Distal barrel 104 is
preferably none other than cannula 12. A plunger 108, having a distal end 110,
sealingly slides in
distal barrel 104 like any conventional plunger. The body of plunger 108
passes through a plunger
element 112 disposed in proximal barrel 106. Plunger element 112 is sized to
sealingly slide in
proximal barrel 106. Plunger element 112 preferably has a recess 113 formed in
a distal end
thereof, recess 113 being sized to snugly receive therein distal end 110 of
plunger 108. A
proximal end of plunger 108 is preferably provided with a small handle I 17.
As seen in Fig. 13B, handle 117 may be used to pull plunger 108 proximally in
the
direction of an arrow 114. Upon sufficient proximal pulling, distal end 110 of
plunger 108 snugly
seats in recess 113. As seen in Fig. 13C, plunger element 112 may now be
pulled proximally in the
direction of arrow 114, and plunger 108 now moves together with plunger
element I 12. Thus,
plunger element I 12 now acts as a new tip of plunger 108 in its travel in
proximal barrel 106.
Since proximal barrel 106 has a larger area than distal barrel 104, the amount
of
material which can be collected with syringe 102 is significantly greater than
a conventional
syringe of the prior art which has only one barrel of the size of the distal
barrel of the present
invention, and yet the smaller diameter of distal barrel 104 allows entry of
syringe 102 into smaller
openings than possible with syringes of the prior art which have a single
barrel of the size of
proximal barrel 106.
Material collected with syringe 102 may be discharged by distally pushing
plunger
element 112 together with plunger 108 in the direction opposite to arrow 114.
Once plunger
element 112 is pushed back to abut against a distal face I 19 of proximal
barrel 106 (the position
shown in Fig. 13B), handle 117 may now be used to distally push plunger 108 so
that distal end
110 of plunger 108 becomes dislodged from plunger element 112 and is free to
be pushed further
into distal barrel 104. Plunger 108 may then be further pushed to completely
discharge the
collected material.
It will be appreciated by persons skilled in the art that the present
invention is not
limited by what has been particularly shown and described hereinabove. Rather
the scope of the
present invention includes both combinations and subcombinations of the
features described
hereinabove as well as modifications and variations thereof which would occur
to a person of skill
in the art upon reading the foregoing description and which are not in the
prior art.
11

Representative Drawing
A single figure which represents the drawing illustrating the invention.
Administrative Status

2024-08-01:As part of the Next Generation Patents (NGP) transition, the Canadian Patents Database (CPD) now contains a more detailed Event History, which replicates the Event Log of our new back-office solution.

Please note that "Inactive:" events refers to events no longer in use in our new back-office solution.

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Event History

Description Date
Inactive: IPC from MCD 2006-03-12
Inactive: IPC from MCD 2006-03-12
Application Not Reinstated by Deadline 2002-08-19
Time Limit for Reversal Expired 2002-08-19
Deemed Abandoned - Failure to Respond to Maintenance Fee Notice 2001-08-17
Inactive: Correspondence - Transfer 2001-05-09
Inactive: Cover page published 2000-05-19
Inactive: First IPC assigned 2000-05-16
Inactive: Notice - National entry - No RFE 2000-05-02
Application Received - PCT 2000-04-28
Application Published (Open to Public Inspection) 1999-03-18

Abandonment History

Abandonment Date Reason Reinstatement Date
2001-08-17

Maintenance Fee

The last payment was received on 2000-03-09

Note : If the full payment has not been received on or before the date indicated, a further fee may be required which may be one of the following

  • the reinstatement fee;
  • the late payment fee; or
  • additional fee to reverse deemed expiry.

Please refer to the CIPO Patent Fees web page to see all current fee amounts.

Fee History

Fee Type Anniversary Year Due Date Paid Date
MF (application, 2nd anniv.) - small 02 2000-08-17 2000-03-09
Basic national fee - small 2000-03-09
Owners on Record

Note: Records showing the ownership history in alphabetical order.

Current Owners on Record
BENNY GABER
Past Owners on Record
None
Past Owners that do not appear in the "Owners on Record" listing will appear in other documentation within the application.
Documents

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Document
Description 
Date
(yyyy-mm-dd) 
Number of pages   Size of Image (KB) 
Description 2000-03-09 11 702
Abstract 2000-03-09 1 61
Claims 2000-03-09 4 192
Drawings 2000-03-09 12 308
Cover Page 2000-05-19 1 62
Representative drawing 2000-05-19 1 5
Notice of National Entry 2000-05-02 1 193
Request for evidence or missing transfer 2001-03-12 1 108
Courtesy - Abandonment Letter (Maintenance Fee) 2001-09-17 1 185
PCT 2000-03-09 11 379